Medical device business record query entrance?
In the State Drug Administration website query, open the "medical equipment" section: (/ylqx/index.html)
Tap the link to enter the site, you will see the page on the right side of a medical device query portal. Don't be in a hurry to click on which to enter, you should first determine their own query of medical equipment products are imported or domestic, if domestic on the point of "domestic devices", if imported, click on the "imported devices". The first thing you can do is to check the information on the record.
Guangzhou, Class II medical device business record how to handle?
The second class of medical devices for the record is also called the second class of medical equipment business for the second class of medical equipment business license need to provide materials:
1, fill out the second class of medical equipment business enterprise filing form;
2, a copy of the business license of the enterprise, the official seal, and the legal representative of the ID card, academic certificate, etc., must be a pharmaceutical university graduate college degree or above;
3, business premises as well as warehouse address of the geographic location map, floor plan, documents proving ownership of the house or a copy of the lease contract, the address can not be residential in nature, it must be a street store or office building;
4, other relevant information, such as business facilities, equipment catalog.
How to check the business record of Class II medical devices?
The filing number of the second class of medical equipment business record certificate numbering rules for: XX food and drug supervision and mechanical business preparation XXXXXXXXXX number.
Which: the first X on behalf of the filing department of the province, autonomous region, municipality directly under the central Chinese abbreviation, the second X on behalf of the location of the municipal administrative region of the Chinese abbreviation, the third to six X on behalf of the 4-digit filing year, the seventh to ten X on behalf of the 4-digit filing water number.
One class, two types of three types of device filing and licensing instructions?
One class: no medical device license
The first class of medical devices is a low-risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, and so on, the products and production activities by the municipal food and drug regulatory authorities in the area of the municipal level of the implementation of the filing of management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.
Class II: Municipal Food and Drug Administration for medical equipment business preparedness
Class II medical devices is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as band-aids, condoms, thermometers, blood pressure monitors, oxygen concentrators, nebulizers, etc., common in our daily lives, its products and production activities by the provincial food and drug regulatory departments to implement licensing management, respectively, issued the "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate", "Medical Device Registration Certificate" and "Medical Device Registration Certificate". Issued respectively to the "Medical Device Registration Certificate" and "Medical Device Manufacturing License". Business activities by the municipal food and drug regulatory authorities to implement record management.
Requirements for Class II Medical Devices
1, 45 square feet of storage, including 15 square feet of office space
2, a medical professional as the person in charge of the enterprise
3, the product business directory
Note: In line with the above 3 points, basically can be processed for the record of the second class of medical devices.
Class III: State Drug Administration for medical device license
Class III medical device refers to the implantation of the human body, used to support, maintain life, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Therefore, the state control in this area is very strict, then for a class, class II, a class due to the low degree of risk, only need to apply for an ordinary company on the line, class II has a medium risk, so it is also necessary to do a filing.
The third class of medical devices is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices, such as common infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., its products and production and operation activities, respectively, by the State General Administration of the food and drug regulatory departments at the provincial level and the municipal food and drug regulatory department of the district The implementation of licensing management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License".
For three types of medical device license requirements:
1. Address requirements: general class: office area of not less than 100 square feet, warehouse area of not less than 60 square feet;
2. disposable sterile: office area of not less than 60 square feet, warehouse area of not less than 80;
3. in vitro diagnostic reagents: office area of not less than 60 square feet, warehouse area of Not less than 100 square feet, cold room area of not less than 40 cubic
4. Personnel requirements: three bachelor's degree related medical industry.
For three types of medical equipment license notes:
1, office address needs to be commercial nature, the area of the building area on the real estate license shall prevail;
2, in vitro diagnostic reagents must have a cold room, and 40 cubic meters, medical freezers are useless, it must be a cold room; as it relates to the follow-up teacher to the site survey;
3, three personnel Must be undergraduate medical industry, follow-up for the three types of medical device license, the teacher over there to interview, so this personnel is very important, can not rely on, the annual inspection also involves these three personnel, so the most important for the three types of medical device license is the personnel, the address does not have our XunLing enterprise services can provide, but the personnel can not provide.
4, the company's business license on the registered address needs to be consistent with the actual office address, such as the business license address is the park address, then you need to migrate to the actual office address, or the address we provide, because not every park address can increase the scope of business related to the three types of medical devices, without the scope of this business will not be able to apply for a license for the three types of medical devices;
5, There must be its sales of three types of medical equipment product registration certificate, there is this certificate, in order to determine the three types of medical equipment is qualified regular, subsequent application for three types of medical equipment license,, submit materials, this product registration certificate is one of the most important materials.
Retail pharmacies need to record the scope of business?
Retail pharmacies operating Class II medical devices need to be filed retail pharmacies need to record the business scope of Class II medical devices
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